PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) issues.
Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu
Ribavirin
PSUR-outcome
|
08/09/2021
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Hydroxyzine
PSUR-outcome
|
30/08/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Baclofen
PSUR-outcome
|
30/08/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Benazepril
PSUR-outcome
|
27/08/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Posaconazole
PSUR-outcome
|
26/08/2021
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Polystyrensulfonat
PSUR-outcome
|
11/08/2021
Further information is available on the EMA website.
Perindopril
PSUR-outcome
|
11/08/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Donepezil
PRAC signal recommendation
|
04/08/2021
Risk for cardiac conduction disorders including QT prolongation and Torsade de Pointes. Further information and the changes to the product information in all EU languages are available on the EMA website.
Octreotide
PRAC signal recommendation
|
04/08/2021
Risk for pancreatic exocrine insufficiency. Further information and the changes to the product information in all EU languages are available on the EMA website.
Ceftriaxone
PRAC signal recommendation
|
19/07/2021
Risk for hepatitis. Further information and the changes to the product information in all EU languages are available on the EMA website.
